An interventional study of Metabolaid®-based nutraceutical formulation and Placebo capsules in GLP-1, Weight Loss Trajectory and Emotional Disorder, sponsored by University of Alicante. Completed at 1 site in Spain. Open to participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by University of Alicante · Not applicable, Interventional, and Treatment
This study aims to evaluate the effects of a 12-week nutritional intervention with dietary supplements on individuals who have experienced significant weight loss following the use of GLP-1 receptor agonists or similar weight-loss treatments. The study will investigate whether the combined supplementation protocol can improve body composition, emotional well-being, and gut microbiota diversity after discontinuation of pharmacological treatment.
Participants will be randomly assigned to one of two groups: an intervention group receiving a daily combination of food supplements containing bioactive compounds (including polyphenols and antioxidants) and a placebo group. Both groups will maintain their habitual diet and lifestyle throughout the study.
Primary outcomes include changes in fat-free mass, emotional state, and gut microbiota composition. Secondary outcomes include metabolic markers, appetite regulation, and quality of life indicators.
This project seeks to provide evidence-based strategies for maintaining health and preventing metabolic rebound following rapid weight loss or pharmacologically induced appetite suppression.
The increasing use of GLP-1 receptor agonists and similar drugs has led to significant weight loss in many individuals; however, this is often followed by loss of lean mass, mood alterations, and gut microbiota imbalance. This study explores a nutritional supplementation strategy designed to support metabolic recovery and preserve physiological homeostasis in this population.
This 12-week randomized, double-blind, placebo-controlled clinical trial will include adults aged 25-60 years who have recently lost ≥5% of body weight due to pharmacological treatment or restrictive dietary patterns. Participants will be randomly assigned to one of two groups:
All participants will continue their usual dietary and lifestyle habits. Compliance will be monitored through periodic visits and digital tracking.
Measurements will be taken at baseline and after 12 weeks, including:
The expected outcome is that the supplement will mitigate lean mass loss, improve emotional balance, and restore microbiota diversity after significant weight reduction. Results from this study may contribute to developing safe and effective strategies for post-weight-loss management and metabolic health maintenance.
University of Alicante is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a daily dose of a nutraceutical formulation designed to support weight maintenance and metabolic recovery after weight loss. The supplement contains Metabolaid® (a standardized extract of Hibiscus sabdariffa and Lippia citriodora) aimed at improving gut microbiota composition, emotional well-being, and preserving fat-free mass. The intervention lasts 12 weeks, with two capsules per day, taken with meals.
Dietary Supplement: Metabolaid®-based nutraceutical formulation
Participants will receive a placebo identical in appearance, taste, and packaging to the active supplement. The placebo capsules contain inert excipients without active ingredients.
Dietary Supplement: Placebo capsules
A 12-week supplementation with Metabolaid® to assess changes in body composition, emotional health, and gut microbiota after weight loss.
A 12-week placebo supplementation with capsules identical in appearance to the experimental product, to evaluate differences in body composition, gut microbiota, and emotional parameters.
Change in Fat Mass (%)
To evaluate changes in total fat mass percentage after the 12-week intervention, assessed by bioimpedance analysis (BIODY XPERT ZM).
Time frame: Baseline and Week 12
Change in Lean Mass (%)
To evaluate changes in total lean body mass percentage after the 12-week intervention, measured by bioimpedance analysis.
Time frame: Baseline and Week 12
Change in Visceral Fat Level
To assess differences in visceral adiposity index obtained from bioimpedance measurements before and after supplementation.
Time frame: Baseline and Week 12
Change in Body Weight (kg)
To evaluate changes in body weight following the 12-week supplementation period.
Time frame: Baseline and Week 12
Change in BMI (kg/m²)
To assess changes in body mass index calculated as weight (kg) divided by height squared (m²).
Time frame: Baseline and Week 12
Change in Waist Circumference (cm)
To measure changes in abdominal circumference as an indicator of central adiposity.
Time frame: Baseline and Week 12
Change in Hip Circumference (cm)
To record changes in hip circumference to calculate waist-to-hip ratio.
Time frame: Baseline and Week 12
Change in Gut Microbiota Diversity
To evaluate changes in microbial alpha and beta diversity using 16S rRNA sequencing of stool samples.
Time frame: Baseline and Week 12
Change in Abundance of Key Gut Microbial Taxa
To analyze specific bacterial taxa abundance associated with metabolic health before and after the intervention.
Time frame: Baseline and Week 12
Change in Appetite Score (VAS)
Description: Appetite perception will be evaluated using a Visual Analogue Scale (VAS) consisting of a 100-mm horizontal line, where 0 represents "no appetite at all" and 100 represents "extremely high appetite." Participants will mark their perceived level of appetite on the line, and the score will be measured in millimeters from the left end. Range: 0-100 mm. Interpretation: Higher scores indicate greater appetite perception.
Time frame: Baseline and Week 12
Change in Satiety Score (VAS)
Description: Perceived fullness or satiety will be evaluated using a Visual Analogue Scale (VAS) consisting of a 100-mm horizontal line, where 0 represents "not at all full" and 100 represents "extremely full." Participants will indicate their perceived level of satiety on the line, and the score will be measured in millimeters from the left end. Range: 0-100 mm. Interpretation: Higher scores indicate greater perceived satiety.
Time frame: Baseline and Week 12
Change in Physical Activity Level (IPAQ Total Score)
Description: Physical activity levels will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), which records activity performed over the previous 7 days. The questionnaire includes 7 items covering walking, moderate, and vigorous activities. The total score is expressed in MET-minutes per week and categorized into low, moderate, or high activity levels. Range: 0 to unlimited MET-min/week. Interpretation: Higher scores indicate greater physical activity levels.
Time frame: Baseline and Week 12
Change in Total Energy Intake (kcal/day)
To quantify changes in daily energy consumption from dietary recalls.
Time frame: Baseline and Week 12
Change in Macronutrient Distribution (%)
To evaluate changes in carbohydrate, protein, and fat intake percentages.
Time frame: Baseline and Week 12
Change in Fasting Glucose (mg/dL)
To assess changes in fasting blood glucose levels as a metabolic indicator.
Time frame: Baseline and Week 12
Change in Fasting Insulin (µU/mL)
To measure insulin levels to assess metabolic response to supplementation.
Time frame: Baseline and Week 12
Change in Total Cholesterol (mg/dL)
To measure total cholesterol concentration in fasting blood samples.
Time frame: Baseline and Week 12
Change in HDL Cholesterol (mg/dL)
To assess HDL cholesterol changes after supplementation.
Time frame: Baseline and Week 12
Change in LDL Cholesterol (mg/dL)
To evaluate low-density lipoprotein cholesterol levels before and after intervention.
Time frame: Baseline and Week 12
Change in Triglycerides (mg/dL)
To determine the impact of supplementation on triglyceride concentrations.
Time frame: Baseline and Week 12
Change in C-Reactive Protein (mg/L)
To assess systemic inflammation through C-reactive protein levels.
Time frame: Baseline and Week 12
Change in Interleukin-6 (pg/mL)
To evaluate inflammatory status through IL-6 concentrations
Time frame: Baseline and Week 12
Change in TNF-alpha (pg/mL)
To measure tumor necrosis factor-alpha as an additional inflammatory marker
Time frame: Baseline and Week 12
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Body-Weight Trajectory
University of Alicante